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| |  ACC: Novastan (Argatroban) Improves Outcome In Heparin-Induced Thrombocytopenia HOUSTON, TX -- March 13, 2000 -- Texas Biotechnology Corporation announced, at the American College of Cardiology (ACC) Annual Meeting held in Anaheim, CA, the presentation of Phase III clinical trial results supporting the use of Novastan (argatroban) Injection as anticoagulant therapy in patients with heparin-induced thrombocytopenia (HIT). Overall, the results of the study showed that Novastan significantly improved patient outcomes in the primary efficacy endpoint and provided rapid, adequate anticoagulation with no increase in bleeding as compared to the control group. Novastan is a synthetic direct inhibitor of thrombin, a key factor in the formation of blood clots. Bruce Lewis, M.D. Associate Professor of Medicine, Loyola University Medical Center and Chief, Section of Cardiology, Catholic Health Partners presented data from the pivotal trial, which involved 304 patients treated with Novastan compared to 193 historical control patients. Of the 304 patients who received Novastan -- 160 patients had HIT (patients with a drop in platelets but no thrombosis at baseline) and 144 had HITTS (patients with thrombosis at baseline). The control group had 147 HIT patients and 46 HITTS patients. In this clinical trial, data were analyzed and found to be positive using two statistical methodologies: time-to-event and categorical. The primary endpoint of the study protocol called for the evaluation of all-cause death, all-cause amputation or new thrombosis over a 37 day study period. In the time-to-event analysis, historical control patients with HIT had a 68 percent greater risk of experiencing death, amputation or new thrombosis; while historical control patients with HITTS exhibited a 75 percent greater risk of experiencing one of the same endpoints. In this analysis, statistical significance in favor of Novastan was achieved in both the HIT and the HITTS study arms. The categorical analysis showed a significant improvement in the composite endpoint outcome in patients with HIT and HITTS treated with Novastan versus those in the historical control group. In Novastan treated patients there was a significant reduction in new thrombosis and death due to thrombosis in both study arms. Further NOVASTAN treated patients rapidly achieved adequate anticoagulation and, relative to controls, experienced significant platelet count improvement. Bleeding events, typically a significant side effect of an anticoagulant therapy, were not different between the groups. Heparin-induced thrombocytopenia is an immune-mediated syndrome caused by an adverse drug reaction to heparin and occurs in approximately 300,000 patients receiving heparin. When a patient is diagnosed with HIT, immediate discontinuation of heparin is advocated for managing the patient, however, continued anticoagulation is often required. The initial clinical development program for Novastan has focused on developing the drug as an anticoagulant for the treatment of HIT. On February 22, Texas Biotechnology announced that it had received an approvable letter from the U.S. Food & Drug Administration for NOVASTAN as an anticoagulant for prophylaxis (prevention) and treatment of thrombosis in patients with HIT. Under the 1997 agreement with SmithKline Beecham (SB), SB has the rights to market and co-develop Novastan in the United States and Canada as anticoagulant therapy for patients with HIT. Texas Biotechnology has the right to co-promote Novastan in North America for indications other than HIT. Related Links: Novastan (argatroban) , SmithKline Beecham and Texas Biotechnology Corporation.
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